The following data is part of a premarket notification filed by Medicis Technologies Corporation with the FDA for Liposonix System, Model 1 P00xxxx.
| Device ID | K100874 |
| 510k Number | K100874 |
| Device Name: | LIPOSONIX SYSTEM, MODEL 1 P00XXXX |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | MEDICIS TECHNOLOGIES CORPORATION COLUMBIA SQUARE 555 13TH STREET NW Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan MEDICIS TECHNOLOGIES CORPORATION COLUMBIA SQUARE 555 13TH STREET NW Washington, DC 20004 |
| Product Code | OHV |
| CFR Regulation Number | 878.4590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-30 |
| Decision Date | 2011-08-19 |
| Summary: | summary |